drugset / Trial / NCT07839455

Oral and Topical Phytocannabinoids for Psoriasis

NCT07839455 ↗

RandomizedParallel-groupOpen-labelTreatment

Summary

Psoriasis is a chronic inflammatory skin disease that affects approximately 2% of the global population and is frequently associated with psychiatric comorbidities such as anxiety and depression. Although conventional treatments, including topical corticosteroids and biologic agents, may be effective, many patients face challenges related to treatment adherence, adverse effects, and the psychosocial impact of the disease. This open label study aims to investigate the efficacy and acceptability of medicinal cannabis formulations administered orally and topically in the management of mild to moderate psoriasis. 37 participants will be included and will use full spectrum cannabis formulations in the (1:1:1) CBD:CBG:THC ratio at a concentration of 20 mg/ml. The protocol will have a total duration of 180 days, consisting of 60 days of isolated treatment followed by 120 days of combined treatment. Efficacy will be assessed using validated instruments, including PASI, DLQI, BDI II and BAI, the Visual Analog Scale for pruritus intensity, the Cosmetic Acceptability Scale, and the Treatment Satisfaction Scale. The use of cannabis formulations is expected to promote clinical improvement of skin lesions, reduction of subjective symptoms such as pruritus and discomfort, and a positive impact on patients quality of life. This study seeks to contribute to the generation of evidence, regarding the efficacy, safety, and acceptability of therapeutic cannabis use in the dermatological context.

Timeline

Start
2025-11-01
Primary completion
2026-10-01
Completion
2027-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Cannabidiol Other / unclassified 10 mg Oral
Subject Cannabidiol Other / unclassified — Topical
Subject Cannabigerol Small molecule 10 mg Oral
Subject Cannabigerol Small molecule — Topical
Subject delta-9-tetrahydrocannabinol Other / unclassified 10 mg Oral
Subject delta-9-tetrahydrocannabinol Other / unclassified — Topical

Indications